Benzinga | Jul 31, 2020 05:30AM EDT

Tiziana Life Sciences Announces Submission of Patent Application for Nasal Administration of Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, for Treatment of COVID-19 Patients

Tiziana Life Sciences plc (NASDAQ:TLSA) is pleased to announce that it has submitted a patent application for the potential use of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody (mAb), for the treatment of COVID-19 either alone or in combination with other anti-viral drugs. Recent clinical studies imply that a combination of anti-inflammatory and anti-viral drugs may be more effective to treat patients at different stages of COVID-19 disease.

Nasal administration with Foralumab could potentially modulate or stimulate immune system to suppress cytokine storm and reduce respiratory failure in

COVID-19 patients

Nasal administration of Foralumab may be combined with other anti-viral drugs to improve treatment efficacyTiziana has a worldwide exclusive license for nasal administration of Foralumab and other anti-CD3 mAbs for the treatment of neurodegenerative and other diseases. The Company previously announced development of a robust formulation and delivery of Foralumab using a nasal spray device and the successful completion of a Phase 1 trial demonstrating that the treatment was well-tolerated and showed positive immunomodulatory effects as measured by biomarker analysis ( https://www.tizianalifesciences.com/news-item?s=2018-11-28-tiziana-announces-initiation-of-phase-1-clinical-trial-with-nasal-administration-of-foralumab-a-fully-human-anti-cluster-definition-3-monoclonal-antibody-anti-cd3-mab-in-healthy-volunteers).

Additionally, Tiziana also reported the successful completion of a Phase 1 trial with oral administration of Foralumab, demonstrating that the treatment was well-tolerated up to a 5 mg dose ( https://www.tizianalifesciences.com/news-item?s=2020-01-09-tiziana-reports-phase-1-clinical-data-demonstrating-oral-treatment-with-foralumab-a-fully-human-anti-cd3-monoclonal-antibody-is-well-tolerated-in-healthy-volunteers). Importantly, both clinical studies conducted at the Brigham and Women's Hospital and Harvard Medical School, Boston, MA., indicated that the severe toxicities that are commonly associated with intravenous administration of anti-CD3 mAbs were not observed with either oral or nasal administration of Foralumab.

"Nasal administration of Foralumab is a potentially transformative immunomodulatory approach for treating patients with a variety of human diseases. Results from animal studies conducted in our laboratory have established that nasal administration of anti-CD3 induces regulatory T cells that suppress inflammation and ameliorate diseases in animal models. This scientific advancement provides the basis to move forward with clinical development of nasally administered Foralumab in COVID-19 disease," commented Dr. Weiner, who is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham & Women's Hospital. He continued, "Modulating the immune system with nasal anti-CD3 is a first-in-class immunotherapeutic approach to treat COVID-19 disease."

"Our proprietary immunotherapeutic approach using nasal, inhalation and oral administration of mAbs are novel and promising therapies that stimulate or modulate the immune system so that T regulatory cells (Tregs) are supercharged to inhibit inflammation. The common underlying concept in these alternative delivery approaches is to strengthen one's own body defense to fight against inflammation in these diseases. Being a fully human anti-CD3 mAb, we believe Foralumab is most suitable for immunotherapies, as it does not produce an immune response unlike other humanized anti-CD3 mAbs," commented Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences.

The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.